Text Message Intervention for Alcohol Use and Sexual Violence in College Students

Sponsor
Penn State University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05065918
Collaborator
National Institutes of Health (NIH) (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH), University of Pittsburgh (Other)
250
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Study Details

Study Description

Brief Summary

This study is designed to pilot a text message (TM) delivered behavior change intervention to decrease binge drinking and to increase use of sexual violence (SV) harm reduction strategies among college students.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: sexual violence and alcohol use harm reduction text message content
  • Behavioral: alcohol use reduction content
N/A

Detailed Description

This is a prospective, open-label, feasibility trial of a text message-delivered intervention designed to increase use of sexual violence harm reduction strategies and decrease alcohol use among college students.

In this research study, participants will:
  • be asked to complete three surveys, one survey at the start of the study, one at the end of 3 month intervention period, and one at 6 months after enrollment

  • receive one of two sets of text messages for a 3 month intervention period and be asked to respond to some of those text messages

  • Control condition text messages: The control condition will be a version of the TM-delivered alcohol use reduction intervention developed and implemented by Dr. Brian Suffoletto while at the University of Pittsburgh. This intervention has been tested in young adults (age 18-25) recruited from Emergency Department and college settings, and will be used to provide an attention control group for efficacy testing. Prior to typical drinking occasions, individuals planning a drinking event are prompted to consider committing to a drinking limit goal, i.e.: "Would you be willing to set a goal to drink less than X drinks when drinking?". Based on willingness to commit to the goal, a feedback message is provided. During typical drinking periods, individuals receive a goal reminder. Each week, the program provides goal success/failure feedback or drinking quantity feedback. For example, those occasions where an individual committed to a drinking limit goal triggers either messages to reinforce goal successes or reframe goal failures. When an individual did not commit to a drink limit goal, they are provided feedback based on alcohol quantity (e.g. abstinence feedback, high risk drinking feedback).

  • Intervention condition text messages: The multi-target sexual violence harm reduction and alcohol use intervention will use a similar model to the alcohol use reduction intervention previous developed and implemented at the University of Pittsburgh.13-15 Students will be: 1) queried via TM prior to typical drinking days regarding both alcohol use and SV harm reduction goal setting; 2) provided with goal reminders during drinking period; and 3) assessed for goal attainment and given feedback following drinking episodes.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Text Message Intervention for Alcohol Use and Sexual Violence in College Students
Actual Study Start Date :
Nov 4, 2021
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Aug 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Control - alcohol use reduction content

Alcohol use reduction content

Behavioral: alcohol use reduction content
The control condition will be a previously tested TM-delivered alcohol use reduction intervention. Prior to typical drinking occasions, individuals planning a drinking event are prompted to consider committing to a drinking limit goal, i.e.: "Would you be willing to set a goal to drink less than X drinks when drinking?". Based on willingness to commit to the goal, a feedback message is provided. During typical drinking periods, individuals receive a goal reminder. Each week, the program provides goal success/failure feedback or drinking quantity feedback. For example, those occasions where an individual committed to a drinking limit goal triggers either messages to reinforce goal successes or reframe goal failures. When an individual did not commit to a drink limit goal, they are provided feedback based on alcohol quantity (e.g. high risk drinking feedback).

Experimental: Intervention - sexual violence and alcohol use harm reduction content

sexual violence and alcohol use harm reduction content

Behavioral: sexual violence and alcohol use harm reduction text message content
The multi-target sexual violence harm reduction and alcohol use intervention will use a similar model to the alcohol use reduction intervention previous developed and implemented. Students will be: 1) queried via TM prior to typical drinking days regarding both alcohol use and SV harm reduction goal setting; 2) provided with goal reminders during drinking period; and 3) assessed for goal attainment and given feedback following drinking episodes. As with the control condition, post-drinking assessment happens weekly on Sundays. Monday thru Saturday participants will randomly receive or not receive one appropriate message pathway from the message library using the pre-determined pathways for messages.

Outcome Measures

Primary Outcome Measures

  1. number of drinking days per month [3 month follow up]

    as measured using a 30-day timeline follow-back (TLFB)

  2. number of drinking days per month [6 month follow up]

    as measured using a 30-day timeline follow-back (TLFB)

  3. number of binge drinking days per month [3 month follow up]

    as measured using a 30-day timeline follow-back (TLFB)

  4. number of binge drinking days per month [6 month follow up]

    as measured using a 30-day timeline follow-back (TLFB)

  5. use of sexual violence harm reduction strategies [3 month follow up]

    Modified Dating Self-Protection Against Rape Scale (DSPARS). A series of questions about frequency of use of 15 behavioral strategies to protect against sexual assault (e.g. "meet in a public place instead of a private place" and "tell a friend who you are meeting and where"). In addition to use of each strategy, each item will be used to assess knowledge ("How aware of…") and self-efficacy ("How confident in your ability to…") for each strategy. ( ∝ = 0.86).

  6. use of sexual violence harm reduction strategies [6 month follow up]

    Modified Dating Self-Protection Against Rape Scale (DSPARS). A series of questions about frequency of use of 15 behavioral strategies to protect against sexual assault (e.g. "meet in a public place instead of a private place" and "tell a friend who you are meeting and where"). In addition to use of each strategy, each item will be used to assess knowledge ("How aware of…") and self-efficacy ("How confident in your ability to…") for each strategy. ( ∝ = 0.86).

Secondary Outcome Measures

  1. knowledge of sexual violence harm reduction behaviors [3 month follow up]

    Modified Dating Self-Protection Against Rape Scale (DSPARS). A series of questions about frequency of use of 15 behavioral strategies to protect against sexual assault (e.g. "meet in a public place instead of a private place" and "tell a friend who you are meeting and where"). In addition to use of each strategy, each item will be used to assess knowledge ("How aware of…") and self-efficacy ("How confident in your ability to…") for each strategy. ( ∝ = 0.86).

  2. knowledge of sexual violence harm reduction behaviors [6 month follow up]

    Modified Dating Self-Protection Against Rape Scale (DSPARS). A series of questions about frequency of use of 15 behavioral strategies to protect against sexual assault (e.g. "meet in a public place instead of a private place" and "tell a friend who you are meeting and where"). In addition to use of each strategy, each item will be used to assess knowledge ("How aware of…") and self-efficacy ("How confident in your ability to…") for each strategy. ( ∝ = 0.86).

  3. self-efficacy to use sexual violence harm reduction behaviors [3 month follow up]

    Modified Dating Self-Protection Against Rape Scale (DSPARS). A series of questions about frequency of use of 15 behavioral strategies to protect against sexual assault (e.g. "meet in a public place instead of a private place" and "tell a friend who you are meeting and where"). In addition to use of each strategy, each item will be used to assess knowledge ("How aware of…") and self-efficacy ("How confident in your ability to…") for each strategy. ( ∝ = 0.86).

  4. self-efficacy to use sexual violence harm reduction behaviors [6 month follow up]

    Modified Dating Self-Protection Against Rape Scale (DSPARS). A series of questions about frequency of use of 15 behavioral strategies to protect against sexual assault (e.g. "meet in a public place instead of a private place" and "tell a friend who you are meeting and where"). In addition to use of each strategy, each item will be used to assess knowledge ("How aware of…") and self-efficacy ("How confident in your ability to…") for each strategy. ( ∝ = 0.86).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 24 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. age 18-24 years,

  2. current college or university student,

  3. owns a mobile phone with internet access and unlimited text message plan,

  4. reports binge drinking in the past 30 days [>3 drinks for women, >4 drinks men in one sitting]

  5. Able to complete participation in English.

  6. To evaluate messages tailored to prior SV victimization, approximately 50% of the sample will also be purposively recruited for a baseline history of SV.

Exclusion Criteria:
  1. Under 18 years old, over 24 years old

  2. Not currently enrolled in college

  3. Does not own a mobile phone with internet access and unlimited data plan

  4. Does not report binge drinking in the past 30 day

  5. Unable to complete study participation in English

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pennsylvania State University University Park Pennsylvania United States 16802

Sponsors and Collaborators

  • Penn State University
  • National Institutes of Health (NIH)
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • University of Pittsburgh

Investigators

  • Principal Investigator: Jocelyn Anderson, Penn State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jocelyn Anderson, Assistant Professor, Penn State University
ClinicalTrials.gov Identifier:
NCT05065918
Other Study ID Numbers:
  • STUDY00010873
  • K23AA027288
First Posted:
Oct 4, 2021
Last Update Posted:
Aug 10, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 10, 2022